Editor's Notes: New drugs in this article refer to any of the following drugs:
Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;
Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;
First generic drugs in China: the first generic chemical drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization. The term “first generic drug” is commonly used in the Chinese pharma industry but not specified in Chinese regulations.
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In March 2024, China NMPA approved 7 new drugs, among which 4 are chemical drugs and 3 are biological products.
1. Kechow Pharma’s Tunlametinib Capsules (class 1 innovative drug)
2. Shenyang Sinqi Pharma’s Atropine Sulfate Eye Drops
3. Shandong Loncom Pharma’s Calcium Acetate Oral Solution (first generic in China)
4. Jiangsu Hengrui Pharma’s Thiotepa for Injection (first generic in China)
5. Boehringer Ingelheim’s Spesolimab Injection
6. Pfizer’s Sugemalimab Injection
7. Sobi’s Anakinra Injection
1. Tunlametinib Capsules
Generic name | Tunlametinib Capsules |
Brand | 科露平 (Ke Lu Ping) |
Classification | Class 1 chemical drug |
Application type | New drug application (NDA), domestic |
Marketing authorization holder (MAH) | |
Approved | 12/03/2024 |
Time from application acceptance to approval | 392 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | Mitogen-activated protein kinase kinase (MAP2K) |
Indication(s) | Indicated for the treatment of patients with NRAS-mutated advanced melanoma who have previously received immunotherapy. |
2. Atropine Sulfate Eye Drops
Generic name | Atropine Sulfate Eye Drops |
Brand | / |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
MAH | |
Approved | 05/03/2024 |
Time from acceptance to approval | 315 days |
Priority review | Yes (pediatric drug) |
Target(s) | Muscarinic acetylcholine receptor (mAChR) |
Indication(s) | Indicated for delaying the progression of myopia. |
3. Calcium Acetate Oral Solution
Generic name | Calcium Acetate Oral Solution |
Brand | / |
Classification | Class 3 chemical drug |
Application type | Abbreviated new drug application (ANDA), domestic |
MAH | |
Approved | 19/03/2024 |
Time from acceptance to approval | 524 days |
Priority review | No |
Target(s) | Phosphate |
Indication(s) | Indicated for reducing serum phosphorus in patients with end stage renal disease (ESRD). |
Notes | First generic in China |
4. Thiotepa for Injection
Generic name | Thiotepa for Injection |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 19/03/2024 |
Time from acceptance to approval | 1,159 days |
Priority review | No |
Target(s) | Deoxyribonucleic acid (DNA) |
Indication(s) | Indicated as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients (＜18 years old) with class 3 beta thalassemia. |
Notes | First generic in China |
5. Spesolimab Injection
Generic name | Spesolimab Injection |
Brand | 圣利卓 (Spevigo) |
Classification | Class 2.1 therapeutic biological product |
Application type | Biologics license application (BLA), imported |
MAH | |
Approved | 05/03/2024 |
Time from acceptance to approval | 285 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | Interleukin-1 receptor-like 2 (IL1RL2) |
Indication(s) | Indicated for the treatment of acute attacks of generalized pustular psoriasis (GPP) in adult patients. |
6. Sugemalimab Injection
Generic name | Sugemalimab Injection |
Brand | 择捷美 (Cejemly) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, imported |
MAH | |
Approved | 12/03/2024 |
Time from acceptance to approval | 378 days |
Priority review | No |
Target(s) | Programmed cell death 1 ligand 1 (PD-L1) |
Indication(s) | Previously approved: (1) Indicated in combination with pemetrexed and carboplatin for the first-line treatment of non-small cell lung cancer (NSCLC) that is EGFR mutation-negative, ALK-negative, metastatic, and non-squamous. In combination with paclitaxel and carboplatin, the drug is indicated for the first-line treatment of metastatic squamous NSCLC. (2) Indicated for the treatment of patients with unresectable stage III NSCLC which didn't progress after platinum-based concurrent or sequential chemoradiotherapy. (3) Indicated for treating relapsed or refractory extranodal natural killer (NK) T-cell lymphoma (R/R ENKTL). (4) Indicated in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Newly approved: (5) In combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-time treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression (combined positive score [CPS] ≥5). |
7. Anakinra Injection
Generic name | Anakinra Injection |
Brand | 安络定 (Kineret) |
Classification | Class 3.3 therapeutic biological product |
Application type | BLA, imported |
MAH | |
Approved | 12/03/2024 |
Time from acceptance to approval | 550 days |
Priority review | No |
Target(s) | Interleukin-1 receptor antagonist protein (IL-1ra) |
Indication(s) | Previously approved: (1) For the treatment of autoinflammatory periodic fever syndrome (for the treatment of Familial Mediterranean Fever) in adults, adolescents, children, and infants 8 months and older (weighing at least 10 kg). The drug should be used in combination with colchicine. Newly approved: (2) Indicated for the treatment of Still’s disease. |
Contact BaiPharm if you need more details of drug approvals in China.
